PMA P810006S063

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S063
Product code: LMF
Decision date: 2015-04-16
Classification: Agent, Absorbable Hemostatic, Collagen Based
Generic name: Agent, absorbable hemostatic, collagen based
Approval order statement: MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.

Current openFDA PMA Record#

Device: COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC SPONGE COLLASTAT ABSORBABLE COLLAGEN HEMOSTATIC AGENT- MICROFIBRILLAR FORM
Applicant: Integra LifeSciences Corporation
PMA number: P810006
Supplement: S063
Product code: LMF
Generic name: Agent, absorbable hemostatic, collagen based
Decision date: 2015-04-16
Decision code: OK30
Date received: 2015-03-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: MATERIAL CHANGE FOR THE PIPE THAT LEADS TO CROSSLINKING CHAMBER 2, AT THE PLAINSBORO, NEW JERSEY MANUFACTURING LOCATION.